Apply for EU QPPV via BioTalent

Job description

Introduction

An opportunity has arisen for seasoned drug safety professional to join global leading contract research organization providing services to the pharmaceutical industry as EU QPPV.

The role is permanent, full-time and home-based in Ireland or Portugal.

You will be responsible for

Acting as EU QPPV for assigned clients
Acting as single POC for the competent authorities on a 24-hour basis, providing prompt response to any requests
Acting as POC during inspections
Providing oversight over the functioning of the system e.g. SOPs, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance
Supporting the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a RMP agreed in the EU
Ensuring conduct of submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP
Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities

You will bring

Life Science degree (Medical degree or higher medical education preferable
8+ years in PV including previous experience acting as EU QPPV or Deputy QPPV
In-depth knowledge of drug safety regulations, industry practices and standards (ICH, GVP, GCP, CIOMS, etc.)
Ability to assign workload and oversee junior staff
Excellent written and verbal communication skills in English

If you don’t want to miss out on this opportunity, please get in touch ASAP.
Email: Valerie.kalna@biotalent.com
Phone: 0203 892 8777